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FDA Watch: New Warning Letter May Signal Resurgence of LDT Enforcement Activity

by | Apr 29, 2019 | Essential, FDA-lir, Industry Buzz-lir, Laboratory Industry Report

From - Laboratory Industry Report After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on… . . . read more

After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on April 4, when the agency issued a warning letter to Inova Genomics Laboratory (Inova) for “illegally marketing” its MediMap genetic tests for predicting a patient’s response to medication, specifically:

  • MediMap Plus, which evaluates patient response to drugs treating, among other things, anesthesia, cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety and diabetes; and
  • MediMap Baby, which analyzes a newborn’s genes that influence response to 24 medications.

The FDA contends that Inova’s website claimed that the tests provide “actionable and informational guidance” and that “[h]ealthcare providers can use these results confidently in making treatment decisions.” In its press release announcing the warning letter, the FDA commented that it “is unaware of any data establishing that Inova’s test can help patients or health care providers make appropriate treatment decisions for the listed drug.” The FDA stated that this warning letter “reflects the agency’s commitment to monitor the pharmacogenetics test landscape and take action when appropriate to address a significant public health risk.”

The Director of the FDA’s Center for Devices and Radiological Health explained that the FDA is “particularly concerned about pharmacogenetic tests that claim to predict patients’ responses to specific medications where such claims have not been established and are not described in the drug labeling and continue to warn patients and health care professionals that they should not rely on these tests for treatment decisions.”

The 2 takeaways from the warning letter:

  1. The FDA can and will take action against LDTs, particularly ones being marketed directly to consumers; and
  2. If the physician who orders the test is affiliated with the lab, the physician order may not be enough to keep the agency from suspecting direct-to-consumer marketing.

Extension of 510(k) Pathway Proposal

The month’s other key development was the FDA’s announced decision to extend for 30 days the comment period for guidance on changing the Section 510(k) premarket review process for new devices and diagnostic tests. The new comment deadline is May 22, 2019. (For an analysis of the proposal, see Lab Industry Report (LIR), February 2019).

New FDA Approvals

Here’s a look at the key FDA approvals announced from late March to mid-April, 2019:

Manufacturer(s) Product(s)
Agilent Technologies Clearance for PD-L1 IHC 22C3 pharmDx assay as companion diagnostic test for Merck’s anti-PD1 immunotherapy pembrolizumab (Keytruda) for non-small cell lung cancer (NSCLC) expanded to include identifying patients with stage III NSCLC who aren’t candidates for surgical resection or definitive chemoradiation, or patients with metastatic NSCLC whose tumors express a PD-L1 Tumor Proportion Score ≥ 1%, and who are eligible for first-line treatment with Keytruda
GenMark Diagnostics 510(k) clearance for ePlex Blood Culture Identification Gram-Negative (BCID-GN) panel assay to detect gram-negative bacteria in blood cultures
Qiagen Clearance for Therascreen FGFR RGQ RT-PCR Kit as companion diagnostic for Janssen Pharmaceutical’s metastatic bladder cancer drug erdafitinib (Balversa)
Bio-Rad Laboratories Clearance for IH-500 automated random access system for blood typing and screening
Bio-Rad Laboratories Clearance for Lyme Total Assay for Lyme disease run on firm’s BioPlex 2200 System
Ortho Clinical Diagnostics Clearance for Vitros XT MicroSlides multitest technology, which enables labs to run two tests simultaneously on one MicroSlide
Aggredyne Clearance for AggreGuide A-100 ADP Assay, cartridge measuring effect of antiplatelet medications targeting P2Y12 platelet receptor
CoaguSense 510(k) clearance for Coag-Sense PT2 meter for professional use in CLIA-waived setting and for self-testing by patients at home
Siemens Clearance for Dimension Vista High-Sensitivity Troponin I assay for measuring cardiac troponin I in plasma using firm’s Dimension Vista system
Beckman Coulter 510(k) clearance for Early Sepsis Indicator hematologic biomarker
Beckman Coulter 510(k) clearance for DxH 520 hematology analyzer, which is designed for clinics, MD offices and other low-volume labs
Beckman Coulter 510(k) clearance for ClearLLab 10C Panels for identifying cell populations by multiparameter immunophenotyping, running on firm’s Navios and Navios EX flow cytometers
Beckman Coulter 510(k) clearance for BD Vacutainer Eclipse UltraFill Blood Collection Needle
AllTest Biotech Clearance for Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), rapid chromatographic immunoassay for detecting single or multiple drugs and drug metabolites in urine
Phadia (owned by Thermo Fisher Scientific) Clearance for EliA Celikey IgG, EliA GliadinDP IgA, and EliA GliadinDP IgG immunoassays
Hitachi Chemical Diagnostics Clearance for Optigen AP 3600 high capacity allergy testing system

New CE Marks & Global Certifications

Notable European CE certifications during the period:

Manufacturer(s) Product(s)
Hologic CE-IVD marking for ThinPrep Genesis processor that prepares slides for cytology and aliquot samples for molecular testing
Ortho Clinical Diagnostics CE marking for Vitros High Sensitivity Troponin I assay to rapidly identify patients suffering from heart attacks and low-risk patients who may be safely discharged from hospital
Sophia Genetics CE-IVD marking for Solid Tumor Solution (STS) molecular diagnostic application
GenePOC CE marking for Carba assay for carbapenemase-producing organisms
Bluejay Diagnostics CE marking for Allereye Tear Total IgE point-of-care test for allergic conjunctivitis
Becton Dickinson CE-IVD marking for BD FACSDuet automated sample preparation system for flow cytometry

Other international clearances announced during the period:

Manufacturer(s) Country(ies) Product(s)
Cytek Biosciences China National Medical Products Administration (NMPA) approval for DxP Athena 13-color flow cytometer
Chembio Diagnostics Brazil Agência Nacional de Vigilância Sanitária (ANVISA) approval for DPP Zika/Dengue/Chikungunya point-of-care system

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